Efficacy Study of Gene Therapy for The Treatment of Acute Leber's Hereditary Optic Neuropathy (LHON) onset within three months
Name: rAAV2-ND4
Description: The Best Corrected Visual Acuity
Measure: BCVA Time: Change from Baseline at 12 monthsDescription: Visual Field index
Measure: Computerized Visual Field Time: Change from Baseline at 12 monthsDescription: Mean Defect
Measure: Computerized Visual Field Time: Change from Baseline at 12 monthsDescription: visual evoked potential
Measure: VEP Time: Change from Baseline at 12 monthsDescription: retinal nerve fiber layer
Measure: RNFL Time: Change from Baseline at 12 monthsDescription: Before and after the treatment,Liver function in plasma will be checked.
Measure: Liver function in plasma Time: Before treatment and in the first ,third,sixth,twelfth month after the treatmentDescription: Before and after the treatment,kidney function in plasma will be checked.
Measure: kidney function in plasma Time: Before treatment and in the first ,third,sixth,twelfth month after the treatmentAllocation: N/A
Single Group Assignment
There is one SNP
This is a multi - center , prospective study of 120 patients with the G11778A mutation in Mt-DNA.This clinical trial recruited 20 patients with the 11778 mutation of MT-DNA onset within three months,20 between 3 to 6 months,20 between 6 to 12 months,20 between 12 to 24 months,20 between 24 to 60 months,and 20 over 60 months.. --- G11778A ---